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2Centre for Economics and Policy in Health, Institute of Medical and Social Care Research, Bangor University, Bangor LL57 1UT

3Department of Primary Health Care, Old Road Campus, Oxford OX3 7LF

Correspondence to: D A Hughes d.a.hughes{at}bangor.ac.uk

Accepted 26 November 2009

Innovation is essential in drug development but is not cheap. Robin Ferner, Dyfrig Hughes, and Jeffrey Aronson examine the challenges of encouraging innovation while ensuring clinical benefit

Two recent reports propose that the NHS should treat innovative medicines favourably.12 The Office for Life Sciences blueprint suggests that promising new drugs for which there are insufficient data for formal appraisal by the National Institute for Health and Clinical Excellence (NICE) should be granted an innovation pass, which will allow limited NHS use. The office has allotted £25m from the Department of Health to fund a pilot of the pass,1 which it hopes will bring early benefit to patients and encourage the development of new medicines. Ian Kennedy, the former chair of the Healthcare Commission, has also recommended that NICE should consider offering incentives to drug companies for innovation.2 Here we consider how innovativeness might be defined in health care, and how NICE and other organisations analysing health technologies might allow it to influence appraisal decisions.

Innovativeness and usefulness

Kennedy suggests that an innovative medicine is one that is new, constitutes an improvement on existing products, and offers “a step-change in terms of outcomes for patients.”2 This last criterion requires a measure of clinical usefulness for NHS patients.

Step changes in clinical usefulness might arise in several ways. The most successful innovations are those that are effective in previously untreatable conditions. Such medicines are most likely to be directed towards a new pharmacological target or to act by a novel pharmacological mechanism. Sildenafil for erectile impotence is a successful example. However, success is not guaranteed, as the case of interferon beta in multiple sclerosis shows (table 1⇓).

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Table 1

Classes of innovation in order of probability of clinical usefulness

Cost effectiveness analyses compare new treatments with the treatments they replace, weighing …